We’re developing room-temperature stable cannabinoid formulations with improved oral bioavailability to seamlessly transition into first-in-man studies.
Using innovative drug delivery technology to solve difficult solubility and formulation development challenges with cannabinoids.
Like the majority of new drug candidates, cannabinoids have low aqueous solubility, resulting in suboptimal bioavailability that can affect all stages of drug development. With heightened interest and remarkable potential for cannabinoid therapeutics to be used for niche indications, an accelerated pathway from development to first-in-man studies will prove to be beneficial. As a CRO with in-depth cannabinoid knowledge and expertise in solving solubility challenges using scalable technologies, Santé Laboratories can work with you to fast-track the formulation development and manufacturing process for clinical investigation.
We are specialized in drug development and contract manufacturing company focused on providing scalable and robust analytical and drug delivery solutions to support the development of cannabinoid therapeutics. Considering the competitive environment in pharmaceuticals, quickly overcoming formulation and analytical challenges to generate proof-of-concept results are mission-critical milestones. Santé Laboratories will work closely with you to implement a successful drug development program by leveraging its broadly applicable drug delivery technology, early-phase capability, and uncompromised passion to advance cannabinoid formulations.
Features of working with Santé Labs:
- Know-how in cannabinoid sciences grounded with exceptional analytical development capabilities to condense timeline to get to clinic quicker by quickly overcoming complex formulation challenges such as instabilities and solubilites
- Specialized drug delivery technology to create successful cannabinoid drug products with patent and indication exclusivity
- Organized to work closely with you to seamlessly execute non-GMP rapid proof-of-concept formulation experiments
with clear success metrics to go from benchtop to clinic
Considering the competitive environment in the pharmaceutical industry, quickly overcoming formulation and analytical challenges and generating proof of concept data are considered “pivotal” milestones, and those focused on achieving early clinical success will increase their program’s likelihood of success.
Know-how, Speed, & Flexibility
For Rapid Cannabinoid Drug Development
Cannabinoids are poorly soluble compounds, and conventional formulation strategies may not be sufficient to achieve target product solubility and bioavailability. Santé Laboratories has extensive expertise in developing non-conventional formulations to address these complex formulation challenges to improve solubility, bioavailability, and stability to streamline development and entry into the clinic.
Analytical Development & Chemistry
Irrespective of the stage of development, the testing of formulations and release of investigational drug products requires a number of appropriate analytical methodologies. With the end goal in mind, Santé Laboratories offers a broad range of analytical services to meet your program specific needs including formulation characterization, method development and validation, and stability testing.
Prior to the investigational use of cannabinoid formulations in humans, a number of pre-clinical studies are required to demonstrate some degree of toxicology and pharmacokinetic understanding. Santé Laboratories will work closely with you and an in-life partner to quickly manufacture placebo and active study supplies and execute necessary IND-enabling studies unique to your therapeutic indication.
Feasibility Studies with Santé Laboratories for Early Success to Enable Commercial Success
A well-defined process to quickly determine if your cannabinoid API(s) is suitable in our drug delivery technology:
Evaluation: Fit-for-purpose service agreements and definition of target product profile
Proof-of-Concept: Abbreviated pre-formulation and formulation characterization studies
Feasibility report and scalability assessment of lead formulations